the philippine legislative and regulatory infrastructure for...

The Philippine Legislative and Regulatory Infrastructure for Nuclear and Radiation Safety

USec. Carol M. Yorobe Department of Science and Technology

Nuclear Energy Forum Novotel Hotel, Quezon City, Philippines 22 August 2017

Outline

Introduction

Philippine Legislative and regulatory infrastructure for nuclear and radiation safety

Philippine Regulatory Bodies for sources of ionizing radiation

Regulated sources of ionizing radiation in the Philippines

Current PNRI nuclear and radiation S & T Programs

Overall assessment of Philippine legal and regulatory infrastructure

Proposed comprehensive nuclear law

Cooperation and Obligations with Global Safety, Safeguards and Security Regime

Summary and Conclusion

3

IONIZING

RADIATION

Potentially harmful or beneficial to

humans…depending on how it is used.

Short wavelength

= high energy

Long wavelength =

low energy

What is radiation?

Energy emitted from a source is generally referred to as radiation.

IONIZING RADIATION

is a

FACT OF LIFE

MODERN

HEALTHCARE

INDUSTRIES

RESEARCH &

DEVELOPMENT

ELECTRICITY

GENERATION

& HEATING

NATURAL

RADIOACTIVITY

IN FOOD &

ENVIRONMENT

Overview on Sources/Applications of Ionizing Radiation

Health effects from exposure to ionizing radiation

Stochastic effects (probabilistic) hereditary effects

radiation-induced cancers

Deterministic effects effects on the early radiologists

consequences of severe accidents

side effects of radiotherapy

Fundamental Safety Principles

KEY to SAFETY and PROTECTION-

National Legal and Regulatory Framework

Philippine Legislative and Regulatory Framework for Nuclear and Radiation Safety

Atomic Energy Facilities, Radioactive Materials and Radiation Generating Devices

Laws

(Republic Act

Presidential Decree

Executive Order)

Standards

Rules and Regulations

Administrative Orders

Regulatory Guides, Bulletins, Information Notice

Republic Act 2067 known as the Science Act of 1958

Republic Act 5207 of 1968 also known as An Act

Providing for the Licensing and Regulation of Atomic

Energy Facilities and Materials

Executive Order 128 of 1987

Republic Act No. 9711 known as the Food and Drug

Administration Act of 2009

Covers technical and administrative requirements e.g. radiation protection, import/export control, transport and waste safety, security, fees and charges

Generally based on international best regulatory practices

Current Regulatory Infrastructure for

Sources of Ionizing Radiation

Office of the President

Department of Science & Technology (DOST)

Philippine Nuclear Research Institute

Department of Health (DOH)

Food & Drug Administration

Center for Device Regulation Radiation Health and Research

Radioactive Materials and Facilities (e.g. NPP, Research Reactor, Medical Cyclotrons,Co-60 teletherapy, brachytherapy (Ir-192, Co-60), Gamma Industrial Radiography, etc.)

Electrically Radiation Generating Devices (e.g. X-Ray, Computed Tomography (CT), Linear Accelerator, etc.)

Mandates of PNRI (EO 128 of 1987)

[a] conduct research and development on the application of radiation and nuclear materials, processes and techniques in agriculture, food, health, nutrition and medicine and in industrial or commercial enterprises;

[b] undertake the transfer of research results to end-users, including technical extension and training services;

[c] operate and maintain nuclear research reactors and other radiation facilities; and

[d] license and regulate activities relative to production, transfer, and utilization of nuclear and radioactive substances.

Mandates of CDRRHR – Radiation Regulation Division ( IRR of RA 9711, 2011)

[a] to regulate the use of ionizing and non-ionizing radiation devices in medicine, dentistry, veterinary medicine, commerce and industry, education and training, research, anti-crime, security, household activities, and all other facilities/establishments and activities where radiation devices are used;

[b] in coordination with the Planning and Policy Office (PPO), to develop policies, standards, regulations, and guidelines for the use of ionizing and non-ionizing radiation devices;

[c] to conduct radiation protection survey and evaluation of radiation facilities and the activities thereat;

[d] to issue appropriate authorizations for medical and non-medical radiation facilities;

[e] to issue certificates of compliance with technical requirements as basis for the issuance of appropriate authorization regarding the use of radiation devices and operation of radiation facilities;

[f] To conduct compliance monitoring of radiation facilities;

[g] in coordination with PPO, to provide technical assistance, consultative and advisory services to stakeholders and other government agencies in the implementation of laws, rules and regulations pertaining to radiation facilities; and

[h] to exercise such other powers and perform such other functions as may be assigned or necessary to carry out its duties and responsibilities.

REGULATED SOURCES OF IONIZING RADIATION IN THE PHILIPPINES

(as of March 2016) Practices No. of facilities and

license holders

Types/No. of Sources Regulatory Body

Medical:

Linear accelerators 33* 40* CDRRHR

Teletherapy

(gamma)

7 199 Co-60 sources (192 Co-60

sources are for gamma knife) PNRI

Brachytherapy

Manual

7 76 Cs-137 sources

I-125 seeds for permanent

implants

PNRI

Brachytherapy

Remote control 11

10 Ir-192 sources

1 Co-60 source

PNRI

Blood Irradiator 3 3 Cs-137 sources PNRI

Nuclear Medicine 52 Unsealed sources for therapy &

diagnosis:

I-131; Tl-201; Tc-99m; Ga-167; Sr-

89; Y-90; I-125 (RIA kits)

PNRI

Medical Cyclotron 2 Production of F-18 PNRI

Source:

1. Licensing, Review, and Evaluation Section (LRES), Nuclear Regulatory Division (NRD), Philippine Nuclear Research Institute (PNRI)\, Department of Science and

Technology

2. Ms. Gladys Cabrera, Center for Device Regulations, Radiation Health and Research (CDRRHR), Food and Drug Administration (FDA), Department of Health


(as of March 2016) Practices No. of

facilities/license

holders


Gamma

industrial radiography

27

97 Ir-192 sources

2 Co-60 sources

3 Se-75 sources

(102 devices)

PNRI

X-ray

industrial radiography

266 710 CDRRHR

Industrial (nuclear)

gauging devices

Am-241:Be & Cs-137, Am-241,

Cf-252, Cs-137, Cs-137, Co-60,

Kr-85, Am-241; Pm-147; Sr-90;

Kr-85, Sr-90, Fe-55, Ni-63, Po-

210 & Pu-238, Kr-85 gas, Po-

210; Th-232, etc

PNRI

Research and education 31 H-3, Ni-63, Am-241, C-14, Cs-137,

Co-60, Fe-55, Sr-90, Tl-204, I-125,

Fe-59, Ba-133, Am-241:Be-7, Cl-

36, P-32, P-33, S-35, U-238, Ge-68

PNRI

Source:


Technology



(as of March 2016)

Practices No. of

facilities/license

holders


X-ray fluorescence

spectroscopy 31 31

CDRRHR

Security equipment (e.g.

baggage x-ray, container

inspection)

110 219 CDRRHR

Dental radiology (alone) 146 176 CDRRHR

Diagnostic and

interventional radiology 6,123 6,821

CDRRHR

X-ray Diffraction Devices 42 42 CDRRHR

Source:


Technology


REGULATED SOURCES OF IONIZING RADIATION IN THE PHILIPPINES (as of March 2016)

Practices

PNRI Facilities

No. of

facilities/licens

e holders


Co-60 multi-purpose

irradiation facility

1 Co-60 pencils (45 units)

PNRI internal regulation

Radioactive waste

management facility

1 Various disused/spent radioactive sources PNRI internal regulation

Electron Beam Facility 1 Specifications: Energy: 1 - 2.5 MeV;

Beam current: Maximum 50 mA;

Beam power: Maximum 100 kW

CDRRHR

Philippine Research

Reactor 1 (shutdown)

1 115 slightly irradiated (General Atomics); 15 fresh (General

Atomics) TRIGA fuel rods g; 4 fission chamber neutron

detectors containing: Total U – 11.65 g, U-235-10.4 g

PNRI

internal regulation

Technetium-99m

Generator Production

Facility

1 Calibration sources (Cs-137; Ba-133; various radionuclides

below exempt level

PNRI

internal regulation

Secondary Standard

Dosimetry Laboratory

1 Cs-137, Co-60, Sr-90, Ba-133, Co-57, Am-Be-241 PNRI

internal regulation

Nuclear Materials

Research Laboratory

1 Am-241, Cs-137, U, Th, K pad, U pad, & Th pad PNRI

internal regulation

GEOGRAPHICAL DISTRIBUTION OF PNRI LICENSEES as of Dec. 2016

17 Source: LRES/NRD/PNRI

Region I 7

Region II 5

Region III 40

Region IV 51

Region V 4

Region VI 9

Region VII 8

Region VIII 2

Region IX 3

Region X 14

Region XI 9

Region XII 4

CARAGA 6

CAR 4

NCR 200

TOTAL: 366

Radioactive Material Licensees:

Industry = 158

Medical = 116

Commercial = 31

Industrial radiography = 28

Research = 31

Atomic Energy Facility Licensees:

Medical cyclotron = 2

PNRI Facilities (self-regulated):

• Co-60 multi-purpose irradiation facility

• Radioactive waste management facility

• Phil Research Reactor (for decommissioning)

• Other practices - R&D

Nuclear and Radiation Research and Technology Development

Food and Agriculture Mutation breeding (rice and alternative crops for resilience

to impacts of climate change

Application of radiotracers and stable isotopes to study agricultural processes (erosion, nutrient and water uptake and utilization)

Application of radiation to control insect pests

- successfully applied to mango pulp weevil (protocol approved by USDA)

and bunchy top banana virus

Plant food supplement from radiation-modified carrageenan

– 30% increase in yield for rice; being tested for more crops and vegetables

CURRENT PNRI NUCLEAR and RADIATION S & T PROGRAMS (1/3)


Health and Medicine Nuclear techniques for harmful algal blooms being transferred to regulatory body

Production of Tc-99m generator and radiopharmaceutical kits

Health products from radiation-modified natural products such as carrageenan, alginate, honey (wound dressing, hemostats)

SIT to combat dengue virus-carrying mosquito



Environment – results are used in aid of environmental regulation and policies Nuclear spectrometric techniques for identification and source apportionment of air pollutants, marine and coastal pollution and other environmental studies

Isotope tracer techniques, radioactive and stable isotopes for water resource management, and for tracing the fate of pollutants from terrestrial sources to aquatic and marine receptors

Isotope tracer techniques for understanding terrestrial and marine processes such as erosion, sedimentation

Environmental radioactivity measurements and monitoring for nuclear emergency preparedness and response


Gamma irradiation (semi-commercial scale) using the Co-60 Multipurpose Irradiation Facility

Nationwide personnel radiation dose monitoring

Radiation instrument calibration

Radioactive waste management

Radioanalytical measurement

Decommissioning of radiation facilities

Cytogenetic analysis for dose assessment

PNRI Nuclear and Radiation Services

The PNRI-DOST continues to enhance public awareness and appreciation of the peaceful uses of nuclear and radiation technology to build and strengthen competency in the field of safety, safeguards and security through:

Education and training

Radiation Technology

Radiation Safety

Nuclear S & T program for secondary schools

Introduction to Nuclear Power

Nuclear S & T information dissemination

Business development and marketing of PNRI technologies

Stakeholders involvement/Public acceptance

In view of the complexity of nuclear and radiation applications and greater emphasis on nuclear safety, countries are amending their laws to provide for the creation of an effectively independent radiation and nuclear safety regulatory body.

In Asia-Pacific region, Australia, China, Indonesia, South Korea, Japan, Malaysia, Thailand, Pakistan, India, New Zealand, Singapore, and Vietnam now have separate nuclear and radiation regulatory bodies from their operating and promotional organizations.

Overall Assessment of Philippine Legal and Regulatory Infrastructure (1/3)

Overall Assessment (2/3) In the Philippines, there are two (2) separate regulatory

authorities for sources ionizing radiation

PNRI under the Department of Science & Technology for ionizing radiation coming from radioactive materials and facilities

CDRRHR /FDA under the Department of Health ionizing radiation electrically generated by devices and equipment ionizing

Creates a potential for differing regulatory policies and safety standards governing activities involving the use of ionizing radiation

Overall Assessment (3/3)

The legislative framework for the control and regulation of sources of ionizing radiation in the country needs to be modernized and rationalized; the primary legal instruments are outdated.

The primary legal instruments mandated the PNRI with the dual function of promoting and regulating the peaceful applications of nuclear energy.

Title of Proposed Bill

“AN ACT PROVIDING FOR A COMPREHENSIVE NUCLEAR and RADIATION REGULATION, CREATING FOR THE PURPOSE, THE PHILIPPINE NUCLEAR REGULATORY COMMISSION, AND APPROPRIATING FUNDS THEREFOR.”

known as the “Comprehensive Nuclear Regulation Act”

Filed under HB No. 00025/01691/02977/03651/04369 17th Congress

Nuclear Bill: Timeline

PNRI formulated an internal regulatory program where the nuclear regulatory division exercises control over RAMs in PNRI

The Secretaries of Health (Dr.

Francisco Duque) and of Science

and Technology (Dr. E. Alabastro)

agreed to the 2004 IAEA

recommendation

A draft nuclear law was crafted by the PNRI with the assistance of IAEA legal experts

Draft legislation was filed by Cong. Joseph Emilio Abaya and Rufus Rodriguez during the 14th Congress. A TWG was created

The draft legislation (HB. 147) was filed by Cong. Gerald Abaya, Cong. Rufus Rodriguez and Cong. Maximo Rodriguez during the 16th Congress.

The draft legislation (HB 00025 by Cong. Francis Abaya/01691 by Cong. Maximo Rodriguez/02977 by Cong. Divina Grace Yu/03651) by Cong. Erico Aristotle Aumentado/04369 by Cong. Joey Salcedo/ 03651 Cong. Seth Frederick Jalosjos/ 04369 by Cong. Joey Salceda was filed during the 17th Congress.

2004 2007 2008 2009 2013 2016

COOPERATION AND OBLIGATION WITH GLOBAL SAFETY, SAFEGUARDS, AND SECURITY REGIME

CONVENTIONS AND TREATIES RATIFIED OR SIGNED (1/5)

SAFETY AND SECURITY Signature Instrument Entry into Force Convention on Early Notification of a Nuclear Accident

Accession

05 Jun 1997

Convention on Assistance in the Case of a Nuclear Accident or Radiological Emergency

Accession

05 Jun 1997

Convention on Nuclear Safety 14 Oct 1994 Joint Convention on the Safety of Spent fuel Management and on the Safety of Radioactive Waste Management

10 Mar 1998

Convention on Physical Protection of Nuclear Materials

19 May 1980

Ratification 08 Feb 1987

Vienna Convention on Civil Liability for Nuclear Damage

21 May 1963

Ratification

12 Nov 1977


SAFETY AND SECURITY Signature Instrument Entry into Force Protocol to Amend the Vienna Convention on Civil Liability for Nuclear Damage

10 Mar 1998

Optional Protocol Concerning the Compulsory Settlement of Disputes

21 May 1963

Ratification

13 May 1999

Convention on Supplementary Compensation for Nuclear Damage

10 Mar 1998

Joint Protocol Relating to the Application of the Vienna Convention and the Paris Convention

21 Sept 1988

International Convention on the Suppression of Acts of Nuclear Terrorism

15 Sept 2005


Safeguards and Verification Signature Instrument Entry into Force Agreement between the Philippines and the IAEA for the Application of Safeguards in connection with the NPT (INFCIRC /216)

Ratification

16 Oct1974

Additional Protocol to Safeguards Agreement

30 Sept 1997

Ratification

26 Feb. 2010

Agreement on the Privileges and Immunities of the IAEA

Acceptance

17 Dec 1962


SCIENCE AND TECHNOLOGY Signature Instrument Entry into Force Fourth Agreement to Extend the 1987 Regional Co-operative Agreement for Research, Development and Training Related to Nuclear Science & Technology (RCA)

Acceptance

21 Sept 2007

Revised Supplementary Concerning the Provision of Technical Assistance by the IAEA (RSA)

03 Mar 1980

03 Mar 1980


TREATY Signature Instrument Entry into Force

Treaty on the Non-Proliferation of Nuclear Weapons (NPT)

1 Jul 1968

Ratification

05 Oct 1972

Southeast Asia Nuclear Weapon-Free Zone Treaty (Bangkok Treaty)

15 Dec 1995

Ratification

21 Jun 2001

Comprehensive Test Ban Treaty (CTBT)

24 Sept 1996

Ratification

23 Feb 2001

Regional and International Cooperation

• International Atomic Energy Agency

• European Union

• USNRC International Regulatory Development Program

• Asian Nuclear Safety Network (ANSN)

• Forum for Nuclear Cooperation in Asia (FNCA)

• ASEAN Network of Regulatory Bodies on Atomic Energy (ASEANTOM)

Summary and Conclusions

Benefits have been derived from the applications of various sources of ionizing radiation in agriculture, industry, medicine, and research

However, sources of ionizing radiation pose danger if not used safely and securely

There are two regulatory bodies for sources of ionizing radiation in the Philippines-PNRI-DOST and CDRRHS-FDA-DOH

There is a need to streamline legal and regulatory infrastructure in compliance with international protection and safety standards for more effective, efficient and harmonized control of sources ionizing radiation

It is important to strengthen cooperation and meet international obligations for safety, safeguards and security.

THANK YOU FOR YOUR ATTENTION

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